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WO2017082478A1 - Composition pharmaceutique visant à prévenir ou traiter l'ostéoporose et contenant un extrait de germe de soja - Google Patents

Composition pharmaceutique visant à prévenir ou traiter l'ostéoporose et contenant un extrait de germe de soja Download PDF

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Publication number
WO2017082478A1
WO2017082478A1 PCT/KR2016/002067 KR2016002067W WO2017082478A1 WO 2017082478 A1 WO2017082478 A1 WO 2017082478A1 KR 2016002067 W KR2016002067 W KR 2016002067W WO 2017082478 A1 WO2017082478 A1 WO 2017082478A1
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Prior art keywords
soyasaponin
extract
composition
osteoporosis
soybean
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English (en)
Korean (ko)
Inventor
서우덕
강현중
이미자
김현영
김선림
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Korea Rural Development Administration
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Korea Rural Development Administration
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae

Definitions

  • the present invention relates to a pharmaceutical composition for the prevention or treatment of osteoporosis comprising a soybean germination extract, specifically, a pharmaceutical composition for the prevention or treatment of osteoporosis comprising a soybean germination extract or a fraction thereof, an individual except the composition It relates to a method for preventing or treating osteoporosis comprising administering to, a food composition for preventing or improving osteoporosis comprising a soybean germ extract or fraction thereof, and a feed composition.
  • Osteoporosis is a disease in which the amount of bone is reduced, the strength of the bone is weakened, and the fracture is easy to occur even with a small impact. Osteoporosis is a problem caused by various fractures, especially femoral fractures or vertebral fractures, caused by weakening of bones rather than the symptoms itself, is a problem by limiting long-term activity, and is known to account for about 15% of the elderly death.
  • the causes of osteoporosis include old age, lack of exercise, low weight, smoking, low calcium diet, menopause, ovarian ablation, and especially in women, bone loss continues after age 30. Proceeds rapidly. In other words, estrogen concentration rapidly decreases until menopause, thereby increasing the activity of osteoclasts, thereby reducing the amount of calcium contained in bone, and weakening the structure maintaining the bone morphology.
  • osteoporosis In order to treat such osteoporosis, hormones, alendronate, calcitonin, calcitonin, raloxifene, Na-F, calcitriol, or bisphosphonate preparations are administered.
  • side effects such as urolithiasis, endometrial cancer, and breast cancer.
  • side effects such as breast cancer, myocardial infarction, and venous thrombosis have been reported for hormone therapy including estrogen or calcitonin, which is currently widely used as a treatment for osteoporosis (JAMA 2002, 288, 872-881; J. Obstet.
  • bisphosphonates have been attracting attention as a novel alternative therapeutic agent for inhibiting osteoclasts.
  • bisphosphonates have been reported to have a low absorption rate, and have been reported to have lesions in the upper airway when incorrectly administered orally. (Clin. Proc. 2002, 77, 1031-1043).
  • the present inventors earnestly researched to develop a therapeutic agent for osteoporosis using a natural-derived component, so that the extract of soybean germination embryos produced by germinating soybean embryos discarded in the manufacturing process of processed products using soybeans improves the proliferation and differentiation ability of osteoblast
  • the present invention was completed by confirming that bone formation by increasing bone density, bone volume and number of bone cells can be used as a prophylactic and therapeutic agent for osteoporosis.
  • One object of the present invention is to provide a pharmaceutical composition for the prevention or treatment of osteoporosis comprising soybean germ extract or fractions thereof.
  • Another object of the present invention is to provide a method for preventing or treating osteoporosis, comprising administering the composition to a subject other than a human.
  • Another object of the present invention to provide a food composition for the prevention or improvement of osteoporosis comprising soybean germ extract or fractions thereof.
  • Another object of the present invention is to provide a feed composition for the prevention or improvement of osteoporosis comprising soybean germ extract or fractions thereof.
  • Soybean germ extract of the present invention improves the proliferative capacity and differentiation capacity of osteoblasts, and shows an effect of increasing the bone density, bone volume and the number of bone cells, can be useful for the prevention or treatment of osteoporosis.
  • FIG. 1 is a graph showing the toxicity of soybean germ extract to osteoblasts. Osteoblasts treated with dimethyl sulfoxide (DMSO) were used as controls, and soybean germ extracts were treated at concentrations of 100, 250 or 500 ⁇ g / mL.
  • DMSO dimethyl sulfoxide
  • Figure 2 is a graph showing the effect of soybean germ extract on osteoblast differentiation. Osteoblasts treated with DMSO were used as a control, and soybean germ extract was treated at a concentration of 100 or 500 ⁇ g / mL.
  • FIG. 3 is a graph showing the effect of soybean germ extract on bone density. Surgically removing the ovaries, the osteoporosis-induced mice (menopause-induced group) was used as a negative control group, soybean germinated embryo extract of 0.1mg / kg was used as a soybean embryo intake group.
  • FIG. 4 is a graph showing the effect of soybean germ extract on bone thickness. Surgically removing the ovaries, the osteoporosis-induced mice (menopause-induced group) was used as a negative control group, soybean germinated embryo extract of 0.1mg / kg was used as a soybean embryo intake group.
  • FIG. 5 is a graph showing the effect of soybean germ extract on bone cell number. Surgically removing the ovaries, the osteoporosis-induced mice (menopause-induced group) was used as a negative control group, soybean germinated embryo extract of 0.1mg / kg was used as a soybean embryo intake group.
  • One aspect for achieving the above object provides a pharmaceutical composition for the prevention or treatment of osteoporosis comprising soybean germ extract or fractions thereof.
  • soybean germination embryo refers to a germinated embryo that germinates an embryo isolated from soybean.
  • the method for producing soybean germ has been known by the inventors' prior studies (Korean Patent Laid-Open No. 2013-0057173), and specifically, the soybean germ may be obtained by germinating embryos separated from soybeans. It is not limited to this.
  • the osteoporosis therapeutic effect of the soybean germ extract is not known at all, and was first identified by the present inventors.
  • the soybean germ extract of the present invention may be obtained by extracting the soybean germ with water, a lower alcohol having 1 to 4 carbon atoms, or a mixed solvent thereof.
  • extract refers to an extract obtained by extracting soybean germ, a diluent or concentrate of the extract, a dried product obtained by drying the extract, a crude or purified product of the extract, or a mixture thereof. It includes the extract itself and extracts of all formulations that can be formed using the extract.
  • the method of extracting the soybean germination embryo is not particularly limited, and may be extracted according to a method commonly used in the art.
  • the kind of extraction solvent used to extract the soybean germ in the present invention is not particularly limited, and any solvent known in the art may be used.
  • Non-limiting examples of the extraction solvent may include water, alcohol or a mixed solvent thereof, these may be used alone or may be used in combination of one or more.
  • alcohol specifically, the C1-C4 alcohol can be used.
  • the fraction of soybean germ extract of the present invention may be obtained by fractionating the extract with water, a lower alcohol having 1 to 4 carbon atoms, a nonpolar solvent, or a mixed solvent thereof.
  • fraction refers to the result obtained by performing fractionation to separate a specific component or a specific component group from a mixture comprising various various components.
  • the fractionation method of obtaining the fraction in the present invention is not particularly limited, and may be performed according to a method commonly used in the art.
  • a method of obtaining a fraction from the extract by treating the extract obtained by extracting the soybean germination of the present invention with a predetermined solvent is not particularly limited, and may be performed according to a method commonly used in the art.
  • the kind of the fractionation solvent used to obtain the fraction in the present invention is not particularly limited, and any solvent known in the art may be used.
  • Non-limiting examples of the fractionation solvents include polar solvents such as water and alcohols; And nonpolar solvents such as hexane, ethyl acetate, chloroform, dichloromethane, and the like. These may be used alone or in combination of one or more.
  • polar solvents such as water and alcohols
  • nonpolar solvents such as hexane, ethyl acetate, chloroform, dichloromethane, and the like. These may be used alone or in combination of one or more.
  • alcohol in the fractionation solvent an alcohol having 1 to 4 carbon atoms may be used.
  • Soybean germ extract of the present invention may be to include isoflavone (isoflavone) or soyasaponin (soyasaponin).
  • isoflavone is a kind of polyphenol compound having a structure similar to estrogen, and is also called phytoestrogen.
  • the isoflavone has a high absorption rate in the body and binds to the estrogen receptor to activate its action.
  • isoflavone examples include (E)-((2R, 3S, 4S, 5R, 6S) -3,4,5-trihydroxy-6- (3- (4-hydroxyphenyl), which is a compound represented by the following Chemical Formula 1 4-oxo-4H-chromen-7-yloxy) -tetrahydro-2H-pyran-2-yl) methyl but-2-enoate or 5-Hydroxy-2- (4-hydroxyphenyl) which is a compound represented by the following formula (2) -4-oxo-4H-chromen-7-yl 6-O-[(2E) -2-butenoyl] hexopyranoside, but is not limited thereto.
  • soybeansaponin is a kind of phytosterol contained in soybean, and is a complex and diverse molecular structure based on an aglycone structure such as a steroid or a triterpenoid. Seems.
  • soya saponin examples include Triacetyl soyasaponin Ab, Diacetyl soyasaponin Aa, Soyasaponin Ab, Soyasaponin Ae, Soyasaponin Af, Soyasaponin Aa, Soyasaponin Ac, Soyasaponin Ag, Soyasaponin Ad, Soyasaponin Ah, Soyasaponin Ba, Soyasaponin Bb, Soyasaponin Bb , Soyasaponin Be, Soyasaponin ⁇ g, Soyasaponin ⁇ a or Soyasaponin ⁇ g, but is not limited thereto.
  • soybean germ extract by applying the soybean germ extract to the UPLC QTOF-mass spectrometer, the main compounds were selected, and it was confirmed that soyasaponin, which is a novel substance of the isoflavone family and a saponin family, was included. (Table 1).
  • Soybean germ extract of the present invention may be to improve the proliferation and differentiation capacity of osteoblasts.
  • osteoblast As used herein, the term "osteoblast” (osteoblast), also called osteoblasts, refers to a cell having the ability to calcify bone tissue by synthesizing and secreting bone matrix and depositing inorganic salts such as Ca and Mg ions on the substrate. do. It is mainly observed at the site where bone formation occurs due to ossification.
  • proliferative capacity means the ability of cells to divide and proliferate. Improving the proliferative capacity means an increase in the number of cells, and by increasing the number of cells, the effect by the characteristics of the cells may be improved.
  • the cell refers to osteoblasts, it is possible to promote the growth of bone by improving the proliferative capacity of osteoblasts.
  • the term "differentiation capacity” means the ability of a less specialized cell to develop into a specific cell, and the improvement of the differentiation capacity means that the specific biological activity of the cell is improved.
  • the cells mean osteoblasts, when osteoblasts differentiation ability is improved, the bone matrix is matured and mineralized by the accumulation of calcium can be promoted the bone new life.
  • the soybean germ extract does not exhibit cytotoxicity even at a concentration of 500 ⁇ g / mL, but rather improves the proliferative capacity of osteoblasts (FIG. 1).
  • the degree of differentiation of osteoblasts is further improved compared to the control (Fig. 2). This suggests that the extract is a safe substance harmless to the human body and promotes bone formation by activating proliferation and differentiation of osteoblasts.
  • Soybean germ extract of the present invention may be to increase bone density, bone volume and the number of bone cells.
  • bone density refers to a measure of bone mineral content of bone and is a criterion for determining bone rigidity.
  • the World Health Organization defines osteoporosis as a bone density less than 2.5 standard deviations, or less than 3%, of the average of young adults. Bone mineral density decreases by 2% every five years after reaching its peak before and after age 30, and about three times faster after menopause.
  • bone mass means the thickness of a bone, and when the bone volume decreases, the bone becomes thin and soft.
  • bone area means the size of a bone, and when the bone area decreases, the bone becomes thin and soft.
  • the extract has the effect of treating osteoporosis by increasing bone density, volume and area to harden bone and activating mineral metabolism of bone tissue.
  • osteoporosis refers to a condition in which the amount of bone decreases and the strength of the bone decreases due to qualitative changes, so that fracture is likely to occur.
  • prevention means any action that inhibits or delays the development of osteoporosis by administration of a pharmaceutical composition comprising the extract of the present invention.
  • treatment means any action that improves or advantageously alters the symptoms of a suspected and developing individual of osteoporosis by administration of the pharmaceutical composition.
  • the pharmaceutical composition of the present invention may include 0.0001 to 50% by weight of the extract relative to the total weight of the composition, and may specifically include 0.01 to 10% by weight, but is not limited thereto.
  • the pharmaceutical composition of the present invention may further include a pharmaceutically acceptable carrier, excipient or diluent commonly used in the manufacture of the pharmaceutical composition, and the carrier may include a non-naturally occuring carrier. Can be.
  • pharmaceutically acceptable in the present invention means to exhibit properties that are not toxic to cells or humans exposed to the composition.
  • the pharmaceutical composition may be formulated in the form of oral dosage forms, external preparations, suppositories, and sterile injectable solutions, such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, and aerosols, respectively, according to conventional methods.
  • sterile injectable solutions such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, and aerosols, respectively, according to conventional methods.
  • carriers, excipients and diluents that may be included in the pharmaceutical composition include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, Calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.
  • Solid form preparations for oral administration include tablets, pills, powders, granules, capsules and the like, and such solid form forms at least one excipient such as starch, calcium carbonate, sucrose or lactose. (lactose), gelatin, etc. are mixed and prepared.
  • lubricants such as magnesium styrate and talc are also used.
  • Liquid preparations for oral use may include various excipients, such as wetting agents, sweeteners, fragrances, preservatives, etc., in addition to water and liquid paraffin, which are commonly used to include suspensions, solutions, emulsions, and syrups. have.
  • Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, suppositories.
  • non-aqueous solvent and suspending agent propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate and the like can be used.
  • As the base of the suppository witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.
  • Another aspect for achieving the above object provides a method for preventing or treating osteoporosis comprising administering the composition to a subject other than a human.
  • administration means introducing a certain substance into an individual in a suitable manner.
  • the term "individual” means all animals, such as rats, mice, and livestock, including humans who may or may develop osteoporosis. As a specific example, it may be a mammal including a human.
  • the method for preventing or treating osteoporosis may include administering a pharmaceutical composition for preventing or treating osteoporosis, including soybean germination extract or a fraction thereof, to a subject other than humans in a pharmaceutically effective amount. have.
  • the term “pharmaceutically effective amount” means an amount sufficient to treat the disease at a reasonable benefit / risk ratio applicable to medical treatment and that does not cause side effects, and the effective dose level is the sex, age of the patient.
  • other medical fields including body weight, health status, type of disease, severity, drug activity, drug sensitivity, method of administration, time of administration, route of administration, and rate of release, duration of treatment, combination or drug used It can be easily determined by those skilled in the art according to factors well known in the art.
  • composition of the present invention may be administered at 0.0001 to 100 mg / kg body weight per day, more specifically at 0.001 to 100 mg / kg body weight, based on solids. Dosing may include administering the recommended dose once daily, or in divided doses.
  • the route of administration and the mode of administration of the composition are not particularly limited, and any route of administration and administration can be achieved as long as the composition comprising the composition can reach the desired site. You can follow the way.
  • the composition may be administered through various routes, oral or parenteral, and non-limiting examples of the route of administration include oral, rectal, topical, intravenous, intraperitoneal, intramuscular, intraarterial, transdermal, nasal What is administered through intralateral or inhalation etc. are mentioned.
  • Another aspect for achieving the above object provides a food composition for preventing or improving osteoporosis comprising soybean germ extract or fractions thereof.
  • improvement means any action in which osteoporosis is improved or beneficially modified by administration of the composition.
  • the term "food” of the present invention is a dairy product including meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, chewing gum, ice cream, various soups, beverages, tea, drinks, alcoholic beverages, Vitamin complexes, nutraceuticals, and health foods.
  • the functional food is the same term as a food for special health use (Food for special health use, FoSHU), in addition to the nutritional supply, the processed food, so that the bioregulatory function appears efficiently, high medical effect Means food.
  • the term "functionality” means obtaining useful effects for health purposes such as nutrient control or physiological action on the structure and function of the human body.
  • the food of the present invention may be prepared by a method commonly used in the art, and the preparation may be performed by adding raw materials and ingredients commonly added in the art.
  • the formulation of the food may also be prepared without limitation as long as the formulation is recognized as a food.
  • Food composition of the present invention can be prepared in various forms of formulation, unlike the general medicine has the advantage that there is no side effect that can occur when taking a long-term use of the drug as a raw material, and excellent portability, the present invention Foods can be taken as a supplement to enhance the effect of preventing or improving osteoporosis.
  • the health food refers to foods having active health maintenance or promotion effect as compared to general foods
  • the health supplement food refers to foods for health supplementation purposes.
  • nutraceutical, health food, dietary supplement are used.
  • the health functional food is a food prepared by adding the extract of the present invention to food materials such as beverages, teas, spices, gums, confections, or the like, encapsulated, powdered, suspensions, etc.
  • food materials such as beverages, teas, spices, gums, confections, or the like, encapsulated, powdered, suspensions, etc.
  • the food composition of the present invention can be consumed on a daily basis, since a high effect can be expected for the prevention or improvement of osteoporosis, it can be very usefully used.
  • the food composition may further include a physiologically acceptable carrier, and the type of carrier is not particularly limited and may be any carrier that is commonly used in the art.
  • the food composition may include additional ingredients that are commonly used in food compositions to improve the smell, taste, time and the like.
  • additional ingredients may include vitamins A, C, D, E, B1, B2, B6, B12, niacin, biotin, folate, panthotenic acid, and the like.
  • minerals such as zinc (Zn), iron (Fe), calcium (Ca), chromium (Cr), magnesium (Mg), manganese (Mn), copper (Cu) and chromium (Cr) may be included. It may also contain amino acids such as lysine, tryptophan, cysteine, valine and the like.
  • the food composition is a preservative (potassium sorbate, sodium benzoate, salicylic acid, sodium dehydroacetic acid, etc.), fungicides (bleaching powder and highly bleaching powder, sodium hypochlorite, etc.), antioxidants (butylhydroxyanisol (BHA), butylhydride) Oxytoluene (BHT), etc.), colorant (such as tar pigment), colorant (sodium nitrite, sodium nitrite, etc.), bleach (sodium sulfite), seasoning (MSG glutamate, etc.), sweetener (ducin, cyclate, saccharin Foods such as sodium, etc.), fragrances (vanillin, lactones, etc.), swelling agents (alum, potassium D-tartrate, etc.), reinforcing agents, emulsifiers, thickeners (foils), coatings, gum herbicides, foam inhibitors, solvents, modifiers It may include food additives.
  • the additive may be selected according to
  • the extract of the present invention may be added as it is or used with other food or food ingredients, and may be appropriately used according to conventional methods.
  • the mixed amount of the active ingredient can be suitably determined according to the purpose of use (prevention, health or therapeutic treatment).
  • the food composition of the present invention may be added in an amount of 50 parts by weight or less, specifically 20 parts by weight or less based on the food or beverage in the manufacture of food or beverage.
  • the active ingredient may be used in an amount above the above range.
  • An example of the food composition of the present invention may be used as a health beverage composition, in which case it may contain various flavors or natural carbohydrates and the like as additional ingredients, such as a general beverage.
  • the above-mentioned natural carbohydrates include monosaccharides such as glucose and fructose; Disaccharides such as maltose and sucrose; Polysaccharides such as dextrin, cyclodextrin; Sugar alcohols such as xylitol, sorbitol, and erythritol.
  • Sweeteners include natural sweeteners such as taumartin, stevia extract; Synthetic sweeteners such as saccharin and aspartame;
  • the ratio of the natural carbohydrate may be generally about 0.01 to 0.04 g, specifically about 0.02 to 0.03 g per 100 mL of the health beverage composition of the present invention.
  • the health beverage composition includes various nutrients, vitamins, electrolytes, flavors, colorants, pectic acid, salts of pectic acid, alginic acid, salts of alginic acid, organic acids, protective colloid thickeners, pH regulators, stabilizers, preservatives, glycerin, Alcohol or carbonation agent and the like.
  • Others may contain fruit flesh for the production of natural fruit juices, fruit juice drinks, or vegetable drinks. These components can be used independently or in combination. Although the ratio of such an additive is not critical, it is generally selected from the range of 0.01 to 0.1 parts by weight per 100 parts by weight of the health beverage composition of the present invention.
  • the food composition of the present invention may include a variety of weight% if it can exhibit a prevention or improvement effect of osteoporosis, but specifically, the extract of the present invention to 0.00001 to 100% by weight or 0.01 to 80% by weight relative to the total weight of the food composition It may include, but is not limited thereto.
  • Another aspect for achieving the above object provides a feed composition for the prevention or improvement of osteoporosis comprising soybean germ extract or fractions thereof.
  • feed means any natural or artificial diet, meal, or the like or component of such meal for the animal to eat, ingest, and digest.
  • the feed may comprise feed additives or feed supplements.
  • the kind of the feed is not particularly limited, and may be used a feed commonly used in the art.
  • Non-limiting examples of the feed may include plant feeds such as cereals, fruits, food processing by-products, algae, fibres, pharmaceutical by-products, oils, starches, gourds or grain by-products; And animal feeds such as proteins, minerals, fats and oils, minerals, fats and oils, single cell proteins, zooplankton or foods. These may be used alone or in combination of two or more thereof.
  • soybean germ was prepared according to the previous study of the present inventors. Specifically, soybean embryos were immersed in running water to germinate, and soybean germ embryos were harvested and lyophilized at about 24 hours, and powdered to obtain soybean germ powder. Fermented alcohol was added to extract the soybean germination powder thus obtained, and it was filtered to obtain a liquid component, and the liquid component was lyophilized to obtain a soybean germination extract.
  • soybean germ extract was applied to UPLC (Ultra Performance Liquid Chromatography) QTOF-mass spectrometer to select major compounds.
  • Soya Saponin Contained in Soybean Germination Extract Compound number Soya Saponin Compound Name One Diacetyl soyasaponin Ab 2 Triacetyl soyasaponin Ab 3 Diacetyl soyasaponin Aa 4 Soyasaponin ab 5 Soyasaponin ae 6 Soyasaponin af 7 Soyasaponin Aa 8 Soyasaponin ac 9 Soyasaponin Ag 10 Soyasaponin ad 11 Soyasaponin Ah 12 Soyasaponin ba 13 Soyasaponin Bc 14 Soyasaponin Bb 15 Soyasaponin Bd 16 Soyasaponin be 17 Soyasaponin ⁇ g 18 Soyasaponin ⁇ a 19 Soyasaponin ⁇ g
  • the cytotoxicity of the extract against osteoblasts was evaluated. Specifically, the osteoblast cell line C3H10T1 / 2 was counted and divided into 96 well plates at 2 ⁇ 10 2 cells / well, and the soybean germ extracts of 100, 250 and 500 ⁇ g / mL concentrations were treated with the cells for 24 hours or 72 hours. Incubated for 2 hours. After completion of the incubation, the water-insoluble formazan formed by the addition of the MTT solution was dissolved in a dimethyl sulfoxide solution, and the absorbance of the dissolved formazan was measured at 595 nm (optical density; OD value). Relative cell activity (%) was evaluated by measuring.
  • the soybean germ extract of the present invention is a safe substance harmless to the human body, and promotes bone formation by activating proliferation of osteoblasts.
  • DMEM with osteoblast cell line C3H10T1 / 2 (Korean Cell Line Bank, Korea) added 10% FBS (fetal bovine serum) and 1% antibiotic (antibiotics; 100 U / ml of penicillin and 0.1 mg / ml of steeptomycin) (Dulbecco's modified eagle medium) was incubated in 96 well plate at 37 °C, 5% CO 2 (95% air) conditions. The cells were counted and counted at 3 ⁇ 10 2 cells / well, and soybean germ germ extracts at concentrations of 100 and 500 ⁇ g / mL were treated with the cells and incubated for 72 hours. After completion of the culture, the relative cell differentiation capacity was evaluated by adding MTT solution to measure the degree of formation of water-insoluble formazan.
  • soybean germ extract of the present invention improves the proliferative and differentiating ability of osteoblasts.
  • the effect of soybean germination extract on the bone density of the animal model that caused osteoporosis by surgically removing the ovary is evaluated.
  • the ovarian was removed using 8-week-old female C57BL / 6 mice to prepare a postmenopausal osteoporosis disease animal. After removal of the skin from the lower abdomen by 1-2cm, the ovary was used by forceps. ovary and oviducts were towed and excised. After one week of ovarian removal, randomized grouping was divided by weight measurement, and oral administration of soy germination embryo extract 0.1, 1 and 5 mg / kg 6 times a week using Sonde.
  • the femur was separated to remove surrounding muscles and fixed with 10% formalin.
  • the bone mineral density was measured by ⁇ CT analysis, and the volume of spongy bone for the total area of bone at the distal femur was evaluated to evaluate the therapeutic effect on osteoporosis.
  • the extract was administered to the osteoporosis-induced animal model according to the method of Example 3-1.
  • the separated femurs were analyzed using ⁇ CT.
  • the cross section was reconstructed using NRecon scanning software. The data viewer was used to align the cross section and the longitudinal section, and the bone density value was calculated from the weight of spongy bone per cm 3 by setting a region, which is 3.5 mm away from the growth plate, in the femur of each group.
  • the extract was administered to the osteoporosis-induced animal model according to the method of Example 3-1.
  • the femur was separated to remove surrounding muscle, paraffin fixed through 10% formalin fixation and EDTA demineralization, and the block was sectioned at 4 ⁇ m.
  • HE Hematoxylin and Eosin staining
  • the area of the spongy bone was measured using an image analysis program for the entire area of the distal femur, which is observed under a 100x magnification of light, and then tabecular bone volume / tissue volume (%). Calculated.
  • the soybean germ extract of the present invention has an effect of treating osteoporosis by increasing bone density, volume and area.

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Abstract

La présente invention concerne une composition pharmaceutique visant à prévenir ou traiter l'ostéoporose et comprenant un extrait de germe de soja. La présente invention concerne, plus précisément, une composition pharmaceutique visant à prévenir ou traiter l'ostéoporose et comprenant un extrait de germe de soja ou une fraction de celui-ci, une méthode de prévention ou de traitement de l'ostéoporose comprenant une étape d'administration de ladite composition à un sujet autre qu'un être humain, et des compositions destinées à l'alimentation humaine ou animale visant à prévenir ou améliorer l'ostéoporose et comprenant un extrait de germe de soja ou une fraction de celui-ci. L'extrait de germe de soja de la présente invention améliore les capacités de prolifération et de différenciation des ostéoblastes, a pour effet d'augmenter la densité osseuse, le volume osseux et le nombre d'ostéocytes, et peut ainsi être utilisé efficacement pour prévenir ou traiter l'ostéoporose.
PCT/KR2016/002067 2015-11-09 2016-03-02 Composition pharmaceutique visant à prévenir ou traiter l'ostéoporose et contenant un extrait de germe de soja Ceased WO2017082478A1 (fr)

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KR1020150156866A KR20170054115A (ko) 2015-11-09 2015-11-09 콩 발아배아 추출물을 포함하는 골다공증의 예방 또는 치료용 약학 조성물
KR10-2015-0156866 2015-11-09

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WO2017082478A1 true WO2017082478A1 (fr) 2017-05-18

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KR102081984B1 (ko) * 2018-04-20 2020-02-26 대한민국 새싹밀 추출물을 포함하는 골다공증 예방 또는 치료용 조성물
JP7227962B2 (ja) * 2018-04-27 2023-02-22 サントリーホールディングス株式会社 筋肉量減少抑制用、筋力低下抑制用、筋肉量増加用又は筋力増加用の組成物
KR102022983B1 (ko) 2019-04-29 2019-09-19 (주)펜즈 골다공증 예방 또는 치료용 조성물
KR102776816B1 (ko) * 2022-02-22 2025-03-11 (주)우리스마트바이오 여성갱년기 증상 예방 및 개선용 조성물, 이를 포함하는 건강기능식품 및 이의 제조방법

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